Coronary AngiographyNCT02752802

DyeVert System RCT

A study testing Diagnostic Coronary Angiogram in people with Coronary Angiography, run by Osprey Medical, Inc at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Angiography
What is being tested?: Diagnostic Coronary Angiogram
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteGermany
Study dates: Apr 2016to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
The subject is ≥ 18 years of age
The subject is willing and able to provide appropriate informed consent.

Who cannot join

Subject is undergoing a STEMI procedure
Subject has previously been diagnosed with anomalous coronary anatomy
Subject has previously underwent coronary artery bypass grafting
Subject has severe peripheral artery disease at access site
Subject is having a staged PCI
The subject is female and currently pregnant
In the investigator's opinion, the subject is not considered to be a suitable candidate

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Hospital of Schleswig-Holstein
Lübeck, 23538

Other trials in Germany

About this study

Official title: Single Site Randomized Control Trial Evaluating the DyeVert System

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

Read the detailed description

This is a prospective, randomized, parallel group, single center clinical evaluation of the DyeVert System. Subjects undergoing a diagnostic coronary angiogram procedure with a 5 French catheter are eligible to participate in this study. The treatment group will use the DyeVert System.

The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.

Randomization will occur following confirmation that the subject meets the inclusion/exclusion criteria and has signed an informed consent. Subjects that are anticipated to be a diagnostic only procedure, but end up being an ad-hoc PCI, can still remain enrolled in the trial. If a subject proceeds to a PCI, data will only be collected through the diagnostic portion of the case.

Conditions: Coronary Angiography
Being tested: Diagnostic Coronary Angiogram
Keywords: Contrast Media, Angiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diagnostic Coronary AngiogramDevice
Diagnostic angiographic procedure with the use of the DyeVert System.

Study groups in NCT02752802
Study group	Role	What they receive
Treatment	Active comparator	The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system. Receives: Device: Diagnostic Coronary Angiogram
Control	Active comparator	The control group will include standard of care for diagnostic coronary angiograms. Receives: Device: Diagnostic Coronary Angiogram

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)
Measured: All data will be collected on the day of the procedure, over an average of 12 hours.

Secondary outcomes (2)

Assessment of the Quality of Angiographic Images Between Groups
To assess the adequacy of the image quality. The proportion of images in which contrast opacification is deemed sufficient to evaluate the desired anatomical structures adequately will be compared between the DyeVert and control groups.
Measured: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
To assess the incidence of Serious Adverse Device Effect for subjects treated with the DyeVert System during the procedure for treatment subjects only.
Measured: All data will be collected on the day of the procedure, over an average of 12 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016May 2016

First posted27 Apr 2016 (estimated)
Study startApr 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Coronary AngiographyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02752802
Sponsor's protocol ID: TP-6495
Status last verified: Jan 2017
First submitted: 22 Apr 2016
Last updated: 28 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; Northern New England Cardiovascular Disease Study Group. Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):693-700. doi: 10.1161/CIRCOUTCOMES.114.000903. Epub 2014 Jul 29.
PubMed 25074372
Gruberg L, Mintz GS, Mehran R, Gangas G, Lansky AJ, Kent KM, Pichard AD, Satler LF, Leon MB. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000 Nov 1;36(5):1542-8. doi: 10.1016/s0735-1097(00)00917-7.
PubMed 11079656
Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, Laskey W; Interventional Committee of the Society for Cardiovascular Angiography and Interventions. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):728-46. doi: 10.1002/ccd.22113. No abstract available.
PubMed 19830793
Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
PubMed 23394215
Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality. A cohort analysis. JAMA. 1996 May 15;275(19):1489-94.
PubMed 8622223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Site Randomized Control Trial Evaluating the DyeVert System
ClinicalTrials.gov ID: NCT02752802
Acronym / sponsor ID: TP-6495
Conditions: Coronary Angiography
Keywords: Contrast Media, Angiography
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Osprey Medical, IncIndustry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 27 Apr 2016 (estimated)
Results: Posted 28 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the amount of contrast media (CM) saved using the DyeVert system in diagnostic angiographic procedures compared to a control group.

Detailed description

The trial will be conducted at one center, located in Germany. A sample size of 96 evaluable subjects will provide a sufficient number of samples to evaluate the primary objectives.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Active comparator	Device: Diagnostic Coronary AngiogramThe treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.
Control	Active comparator	Device: Diagnostic Coronary AngiogramThe control group will include standard of care for diagnostic coronary angiograms.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The subject is indicated for a diagnostic coronary angiogram procedure with a 5 French catheter only.
The subject is ≥ 18 years of age
The subject is willing and able to provide appropriate informed consent.

Key exclusion criteria (7 listed)

Subject is undergoing a STEMI procedure
Subject has previously been diagnosed with anomalous coronary anatomy
Subject has previously underwent coronary artery bypass grafting
Subject has severe peripheral artery disease at access site
Subject is having a staged PCI

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diagnostic Coronary AngiogramDiagnostic angiographic procedure with the use of the DyeVert System.	Device	Control, Treatment

Primary outcome

Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.
Time frame: All data will be collected on the day of the procedure, over an average of 12 hours.
DyeVert is intended to reduce the total amount of contrast media (CM) administered during procedures requiring the injection of contrast media. Clinical evidence has demonstrated that CM can be toxic to the kidneys, leading to contrast induced nephropathy (CIN)

2 secondary outcomes

Assessment of the Quality of Angiographic Images Between Groups
Time frame: AlAll data will be collected on the day of the procedure, over an average of 12 hours.
Assessment of Incidence of Serious Adverse Device Effect for Subjects Treated With the DyeVert System During the Procedure.
Time frame: All data will be collected on the day of the procedure, over an average of 12 hours.

Results and safety

Results posted to the registry on 28 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	48	47
Control	48	48

Primary outcome: Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group.

Time frame: All data will be collected on the day of the procedure, over an average of 12 hours.. Mean (Standard Deviation). Unit: ml

Measure	Treatment n = 47	Control n = 48
Value	38.0 (13.1)	62.5 (12.7)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: At point of discharge from index procedure, approximetly 12 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	2 of 48 (4.2%)	2 of 48 (4.2%)	Not reported
Control	4 of 48 (8.3%)	3 of 48 (6.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25074372Brown JR, Solomon RJ, Sarnak MJ, McCullough PA, Splaine ME, Davies L, Ross CS, Dauerman HL, Stender JL, Conley SM, Robb JF, Chaisson K, Boss R, Lambert P, Goldberg DJ, Lucier D, Fedele FA, Kellett MA, Horton S, Phillips WJ, Downs C, Wiseman A, MacKenzie TA, Malenka DJ; Northern New England Cardiovascular Disease Study Group. Reducing contrast-induced acute kidney injury using a regional multicenter quality improvement intervention. Circ Cardiovasc Qual Outcomes. 2014 Sep;7(5):693-700. doi: 10.1161/CIRCOUTCOMES.114.000903. Epub 2014 Jul 29.
Background: PubMed 11079656Gruberg L, Mintz GS, Mehran R, Gangas G, Lansky AJ, Kent KM, Pichard AD, Satler LF, Leon MB. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000 Nov 1;36(5):1542-8. doi: 10.1016/s0735-1097(00)00917-7.
Background: PubMed 19830793Klein LW, Sheldon MW, Brinker J, Mixon TA, Skelding K, Strunk AO, Tommaso CL, Weiner B, Bailey SR, Uretsky B, Kern M, Laskey W; Interventional Committee of the Society for Cardiovascular Angiography and Interventions. The use of radiographic contrast media during PCI: a focused review: a position statement of the Society of Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):728-46. doi: 10.1002/ccd.22113. No abstract available.
Background: PubMed 23394215Lameire N, Kellum JA; KDIGO AKI Guideline Work Group. Contrast-induced acute kidney injury and renal support for acute kidney injury: a KDIGO summary (Part 2). Crit Care. 2013 Feb 4;17(1):205. doi: 10.1186/cc11455.
Background: PubMed 8622223Levy EM, Viscoli CM, Horwitz RI. The effect of acute renal failure on mortality. A cohort analysis. JAMA. 1996 May 15;275(19):1489-94.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steffen Desch, MD principal investigator

University Hospital of Schleswig-Holstein, Lubeck

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic Coronary Angiogram in people with Coronary Angiography, run by Osprey Medical, Inc at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Total Volume of CM Used Comparing the DyeVert Group to the Control Group. (time frame: All data will be collected on the day of the procedure, over an average of 12 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02752802, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.